EFFECT OF HIGH INTENSITY LASER IN PATELLOFEMORAL PAIN SYNDROME (Laser)

October 11, 2021 updated by: ozluozge, Istanbul Medipol University Hospital

EFFECT OF HIGH INTENSITY LASER THERAPY ON PAIN AND LOWER EXTREMITY FUNCTION IN PATELLOFEMORAL PAIN SYNDROME

The aim of this study is to investigate the effectiveness of high-intensity laser therapy on pain and lower extremity function in the treatment of patellofemoral pain syndrome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants between the ages of 25-45 who were diagnosed with Unilateral patellofemoral pain syndrome by the doctor will be included in the study. Also positive Clarke's test and patellar compression tests will be determined as inclusion criteria. The 45 participants will be randomly divided into three groups. Both groups will receive 2 weeks (5 sessions per week) of therapy. First group patients underwent High Intensity Laser Therapy (HILT) and exercises. Second group patients will be treated by transcutaneous electrical nerve stimulation(TENS), ultrasound (US) and exercise for 10 sessions. Also In the third group patients will be treated with ultrasound (US),interferential current stimulation and exercise. All groups receive the same exercise exercise protocol including muscle strengthening and flexibility training for 12 weeks. The outcomes will be pain intensity measured by visual analog scale (VAS) , knee flexion range of motion (FROM), timed up and go test (TUG),muscle strength measured with handheld dynamometer, Pressure Pain Threshold with an algometry and functionality of knee measured by the Lower extremity functional scale and Kujala patellofemoral questionnaire. Statistical analyzes will be performed to compare amounts at baseline, immediately after treatment, and after 12 weeks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Beykoz
      • Istanbul, Beykoz, Turkey, 34820
        • Ozge Ozlu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unilateral patellofemoral pain syndrome diagnosed by a doctor
  • 25-45 years old
  • pain from prolonged sitting, climbing and descending stairs, running,knee bend more than 3 months
  • positive patellar compression and clarke's tests.

Exclusion Criteria:

  • Previous knee pain, trauma, surgery and other joint diseases,
  • Knee ligament, bursa, meniscus and synovial fold injury or dysfunction
  • Osteoarthritis in the knee joint,
  • Neurological problems that may affect walking
  • Pregnancy
  • No chronic disease
  • Malignancy,
  • Presence of infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High Intensity Laser Therapy Group
Patients underwent High Intensity Laser Therapy (HILT) and exercise for 10 sessions
Other: High Intensity Laser Therapy Group
High Intensity Laser Therapy (HILT) and exercises will be used.
Experimental: Ultrasound and Transcutaneous Electrical Nerve Stimulation Group
Patients will be treated by transcutaneous electrical nerve stimulation(TENS), ultrasound (US) and exercise for 10 sessions
Other: Ultrasound and Transcutaneous Electrical Nerve Stimulation Group
Transcutaneous electrical nerve stimulation(TENS), ultrasound (US) will be applied.
Experimental: Ultrasound and Interferential Current Stimulation Group
Patients will be treated with ultrasound (US) ,interferential current stimulation and exercise for 10 sessions
Other: Ultrasound and Interferential Current Stimulation Group
Ultrasound (US) ,interferential current stimulation and exercise will be used.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain status
Time Frame: 5 minutes
Pain intensity was evaluated with visual analog scale (VAS) in two conditions during activity and resting time. This method, which is developed to determine the intensity of pain to indicate by numbers. It begins with the absence of pain (0) on numerical scale and ends the level of unbearable pain
5 minutes
Range of motion assesment
Time Frame: 10minutes
Universal goniometer will used to measure the joint position and joint range of motion measurements based on Kendall and American Association of Orthopedic Surgeons. The participant will in the sitting position and asked to perform active cervical region flexion, extension, right and left rotation, right and left lateral flexion of the neck movements and performed degrees will recorded
10minutes
Functionality
Time Frame: 5 minutes
The patients will asked to start from a sitting position in a chair, to get up at the command given, to walk the predetermined distance of 3 meters as fast as they could, and to return to their seats. The time from the time they got up from the chair and sat down again will recorded with a stopwatch. Measurements will be repeated 3 times and the average will be recorded in seconds (sec).
5 minutes
Muscle stength assesment
Time Frame: 10 minutes
A myometer will be used to measure the strength of the hamstring and quadriceps muscle groups of all participants. Myometer is an evaluation method that objectively evaluates muscle strength and gives more sensitive results than manual muscle testing.
10 minutes
Pain threshold assessment
Time Frame: 10 minutes
Pressure pain threshold measurement will be measured with an algometer device. Algometers are a device that can be used to define pressure and pressure pain threshold.
10 minutes
Severity and function of patellofemoral pain
Time Frame: 5 minutes
It will be evaluated with the 'Kujala patellofemoral score' system. These scoring system values range from 100 (normal, pain-free, fully functional knee) to 0 (severe knee pain and dysfunction).
5 minutes
Function of lower extremity
Time Frame: 10 minutes
A lower extremity function test will be used to measure lower extremity functionality. It is a test used to measure the functional status of the lower extremities.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: OZGE OZLU, Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ozgeozlu

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

When I published this manuscript in a journal, I would share the results of inividuald participant data of this study with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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